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COGENTIX MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12234901000136543COGENTIX MEDICAL, INC.1N2026-01-01135 Flanders Rd Westborough MA US 01581
22424642242464COGENTIX MEDICAL, INC.1N2026-01-0140 Ramland Rd S ORANGEBURG NY US 10962

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00874485000318Portable LED Light Source - BLS-1000866-258-2182customercare@cogentixmedical.com
00874485000844Flexible Video Esophagoscope (NTSC) - TNE-5000866-258-2182customercare@cogentixmedical.com
00874485002367Flexible Video Bronchoscope (NTSC) - BRS-5100866-258-2182customercare@cogentixmedical.com
00874485002848Flexible Video Bronchoscope (NTSC) Reconditioned - Reconditioned866-258-2182customercare@cogentixmedical.com
00874485002879Flexible Video Esophagoscope (NTSC) Reconditioned - Reconditioned866-258-2182customercare@cogentixmedical.com
00874485002985EndoSheath Technology - EndoSheath Technology for the TNE-5000 Video Esophagoscope866-258-2182customercare@cogentixmedical.com
00874485003180Endoscopic Cytology Brush - 07-9001866-258-2182customercare@cogentixmedical.com
00874485003197Nasal Cytology Brush - 07-9006866-258-2182customercare@cogentixmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
687041446631065K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorEOX2018-11-15
465101208800338K091768VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIESEOQ2009-08-03
687041193496492K072180VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEMFAJ2007-12-18
465101672424177K072180VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEMFAJ2007-12-18
465101774192951K072088FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMSEOX2007-08-29
465101614805623K071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEMHIH2007-11-16
687041739901231K071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEMHIH2007-11-16
465101776853273K021344B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEMEOQ2002-05-24
465101066322782
687041228408619
687041632955395
687041907553034
687042072780751

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EOX22018-11-15
EOQ22009-08-03
FAJ22007-12-18
HIH22007-11-16

PMN#

GUDID#

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